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A Phase Ib/II Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) with Neratinib in Women with Metastatic HER2-Positive Breast Cancer

Protocol Chair: Jame Abraham, MD

Protocol Officer: Samuel Jacobs, MD

Primary Objective Phase Ib: To determine the safety and tolerability of T-DM1 and neratinib in patients with metastatic HER2-positive breast cancer.

Primary Objective: To determine the overall response rate (ORR) in patients with measurable metastatic breast cancer treated with T-DM1 and neratinib.

Patient Population: Metastatic HER2-Positive Breast Cancer

Target Accrual: 63 patients

Status: Closed to accrual

ClinicalTrials.gov Identifier: NCT02236000